黄色なし070827（ItemNo.削除 USAより修正依頼 …...Operation 2007-07-21 Thank you for...

Apex Locator

Canal Measurement Module

Operation Instructions

* This is Canal Measurement Module. Handpiece / LED Module (sold separately) can be easily connected to this module so that preparation can be performed while measuring the canal and the light cure can be applied.

US PAT. 5096419 US PAT. 5122556 US PAT. 5295833 DE PAT. 4126753 DE PAT. 4139424 DE PAT. 4232487

JP PAT. 2873722 JP PAT. 2873725 JP PAT. 3071245 JP PAT. 3071270 JP PAT. 3113109 JP PAT. 3113095

Operation 2007-07-21

Thank you for purchasing ROOT ZX II Canal Measurement Module. For optimum safety and performance, read this manual thoroughly before using the unit and pay close attention to warnings and notes. Keep this manual in a readily accessible place for quick and easy reference. This manual contains essential safety information.

CONTENTS

Page

1. Prevent Accidents.............................................................................................................................. 1

2. Parts Identification ............................................................................................................................ 6

3. Assembling the Unit.......................................................................................................................... 7

4. Before Using the Unit ....................................................................................................................... 8

Connecting the Probe Cord............................................................................................................ 8 Checking the Function ................................................................................................................... 8 Checking the Function with the Tester .......................................................................................... 9

5. Operating the Unit........................................................................................................................... 10

Operation Panel Display and Switches ........................................................................................ 10 Setting and Changing Memory .................................................................................................... 10 Meter Display .............................................................................................................................. 11 Operating the Unit ....................................................................................................................... 12 Root Canals not suitable for Electronic Measurement Reading .................................................. 14 EMR and Radiography ................................................................................................................ 16

6. After Using the Unit........................................................................................................................ 17

7. Sterilization and Replacement Parts................................................................................................ 19

Sterilization.................................................................................................................................. 19 Replacement Parts........................................................................................................................ 19 Storage ......................................................................................................................................... 19

8. Maintenance and Inspection............................................................................................................ 20

9. Troubleshooting .............................................................................................................................. 21

10. Replacement Parts List.................................................................................................................... 22

11. Technical Description...................................................................................................................... 23

Appendix- Electromagnetic declaration ................................................................................................ 25

12. Warranty.......................................................................................................................................... 29


1. Prevent Accidents

Most operation and maintenance problems result from insufficient attention being paid to basic safety precautions and not being able to foresee the possibilities of accidents.

Problems and accidents are best avoided by foreseeing the possibility of danger and operating the unit in accordance with the manufacturer’s recommendations.

First thoroughly read all precautions and instructions pertaining to safety and accident prevention; then, operate the equipment with the utmost caution to prevent either damaging the equipment itself or causing bodily injury.

Note the meaning of the following symbols and expressions:

WARNING This warns that it may result in serious injury of the patient or operator if the instructions are not followed properly.

PROHIBITION The user can not use in such a way that may result in serious injury of the

patient or operator.

NOTE This alerts the user to the possibility of damage to the equipment, potential injury of the patient or operator, or important points concerning operation and performance.

The user ( e.g. the hospital, clinic etc. ) is the party responsible for the maintenance and proper operation of ROOT ZX II dental device.

ROOT ZX II dental device must only be operated by dentists and other legally licensed professionals.

Do not use this equipment for anything other than its specified purpose.


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WARNING • This unit must not be connected to or used in combination with any other apparatus or system. It must

not be used as an integral component of any other apparatus or system. J. Morita Mfg. Corp. will not be responsible for accidents, equipment damage, bodily injury or any other trouble which results from ignoring this prohibition.

• Accurate canal measurement is not always possible depending on the shape and condition of the tooth as well as a decline in the equipment’s performance.

• Do not use damaged file holders; an accurate measurement can not be made with a damaged file holder. • When continuous tone is heard while the main power switch is on and without any operation, some

electrical part may be malfunction. Do not use the unit and send the unit to J. Morita regional office for repairing.

• This unit is for prescription use only. • A rubber dam should be used when performing endodontic treatment. • Caution: US Federal law restricts this unit to sale by or on the order of a dentist in U.S.A. • Check the unit’s operation before each patient. If the indicators in the display do not all appear

normally, the instrument may not be able to make an accurate measurement. In this case, stop using the instrument and have it repaired. ( see page 9 )

• Never use the unit if the battery power indicator is flashing on and off. The unit will not function properly if the battery power is low. ( see page 10 )

• Check the settings displayed after selecting memories. ( see page 10 ) • In some cases such as a blocked canal, a measurement cannot be made. ( see page 11 ) • Always check the measurement with an x ray. In some cases, an accurate measurement cannot be

made because of the canal shape, unusual cases, or poor performance of the instrument. ( see page 11 ) • Stop using the instrument immediately if you sense something odd or abnormal while taking a

measurement. ( see page 11 ) • Do not use an ultrasonic scaler with the contrary electrode attached to the patient. This is dangerous

because electrical noise from the scaler could interfere with canal measurements and motor operation. ( see page 12 )

• Make sure that the contrary electrode, file holder, handpiece file electrode, etc., do not come into contact with an electric power source such as an electrical socket. This could result in a severe electrical shock. ( see page 12 )

• Do not use the unit if the battery power display is flashing. The unit may not function properly if the battery power is low. ( see page 17 )

• Autoclave file holder and contrary electrode after each patient. ( see page 19 ) • The DP-ZX-VL needs special precaution regarding EMC and needs to be installed and put into service

according to the EMC information provided in the Accompanying Documents. • Portable and mobile RF communications equipment can affect the DP-ZX-VL. • Use of the parts other than those accompanied or specified by J. Morita Mfg. Corp. may result in

increased EMC emissions or decreased EMC immunity of the DP-ZX-VL. • The DP-ZX-VL should not be used adjacent to or stacked with other equipment and that if adjacent or

stacked use is necessary, the DP-ZX-VL should be observed to verify normal operation in the configuration in which it will be used.


PROHIBITION • Do not use this unit in conjunction with an electric scalpel or on patients who have a pacemaker. • Do not use this unit in the medical operation room. • Blocked canals cannot be accurately measured. • This unit must not be connected to or used in combination with any other apparatus or system. It must

not be used as an integral component of any other apparatus or system. J. Morita Mfg. Corp. will not be responsible for accidents, equipment damage, bodily injury or any other trouble which results from ignoring this prohibition.

• Illumination devices such as fluorescent lights and the Film viewer which use an inverter can cause ROOT ZX II to operate erratically. Do not use ROOT ZX II near devices such as these.

• Electromagnetic wave interference could cause this device to operate in an abnormal, random and possibly dangerous manner. Cellular phone, transceivers, remote controls and all other devices which transmit electromagnetic waves located inside the building should be turned off.


Page4

NOTE • Canal Measurement Module is shipped without the batteries installed. Remove the cover and install

the 3 AA batteries. ( see page 7 ) • Do not reverse the plus and minus poles. ( see page 7, 18 ) • Never allow the spring contact to push against the edge of the battery. This could damage the outer

cover causing a short or a leakage of battery liquid. ( see page 7, 18 ) • If the catch on the bottom is not back in its original place after attachment, push it in the direction

shown by the arrow in the illustration. ( see page 7, 18 ) • After installation, give the cover a light tug to confirm it is securely attached. ( see page 7, 18 ) • Handle Canal Measurement Module carefully; do not drop, bump or expose it to other kinds of impacts

or shocks. Rough handling could cause damage. ( see page 8 ) • Make sure the plug is securely plugged into the jack. A poor connection can cause malfunction. ( see

page 8 ) • Do not drop anything on or bang the plug after it has been inserted into the jack. ( see page 8 ) • Make sure to match colors of the file holder and contrary electrode to the probe cord. ( see page 8 ) • Measurements cannot be made if these connections are reversed. ( see page 8 ) • Do not let the file touch the gums. This will cause the meter to jump to Apex. ( see page 11 ) • If the canal is extremely dry, the meter may not move until it is quite close to the apex.

If the meter does not move, try moistening the canal with oxydol or saline. ( see page 11 ) • Occasionally the canal length indicator bar makes a sudden and large movement as soon as the file is

inserted into the root canal, but it will return to normal as the file is advanced down towards the apex. ( see page 11 )

• The contrary electrode could cause an adverse reaction if the patient has an allergy to metals. Ask the patient about this before using the contrary electrode. ( see page 12 )

• Take care that medicinal solutions such as formalin cresol (FC) or sodium hypochlorite do not get on the contrary electrode or the file holder. These could cause an adverse reaction such as inflammation. ( see page 12 )

• Always clip the file holder to the upper part of file shaft, near the handle. The metal and plastic part of the file holder can be damaged if they are attached to the file’s cutting part or the transition to the cutting part. ( see page 12 )

• Use files and reamers with plastic handles only. If the file has a metal handle, electrical leakage will occur when the handle is touched by fingers and it will prevent an accurate root canal measurement. Even if the file handle is made of plastic, make sure not to touch the metal part of the file with finger. ( see page 13 )

• Do not use damaged file holders. An accurate measurement cannot be made using a damaged file holder. ( see page 13 )

• Clip the file as shown in illustration #1 below. If the file is forced into the position shown in illustration #2, it may not make an accurate measurement and the file holder could be damaged. ( see page 13 )

File or Reamer

Cutting part and transition to cutting part.

* Do not clip onto this part!

Handle

Metal part of file holder

2

1


NOTE • Make sure to take an x-ray to check the results. ( see page 13 )

• When disconnecting and connecting the contrary electrode, probe cord and file holder, never pull or push on the cords themselves; always grip the connectors. ( see page 17 )

• Do not wrap the probe cord around the body of the main tube. ( see page 17 )

• Always use alkaline AA batteries. ( see page 18 ) • Never use rechargeable nickel-hydrogen or nickel-cadmium

batteries. ( see page 18 )

• Replace all three batteries at the same time. ( see page 18 ) • Make sure that the plus and minus poles are correctly aligned. ( see page 18 ) • Never use batteries that are leaky, deformed, discolored or otherwise abnormal. ( see page 18 ) • Dispose of old batteries according to local codes and regulations. ( see page 18 ) • In case of battery leakage, carefully dry the battery terminals and remove all of the leaked liquid.

Replace the battery with a new one. ( see page 18 ) • Do not sterilize in any way other than autoclave. ( see page 19 ) • Thoroughly clean and wash the components before autoclaving. If chemical solutions or foreign

debris are not removed, autoclaving could damage or deform the components. ( see page 19 ) • Autoclave and dry temperatures must not exceed 135°C (275°F). ( see page 19 ) • Any chemicals or foreign debris left on instruments could cause them to malfunction or could cause

discoloration. ( see page 19 ) • It is highly recommended to put the contents in a sterilization pouch for autoclaving. ( see page 19 ) • Never autoclave probe cord. ( see page 19 ) • Never wipe probe cord with any type of alcohol except Ethanol for Disinfection (Ethanol 80 vol%). ( see

page 19 ) • Occasionally, static electricity produced by wiping the liquid crystal display with a dry cloth may affect

the appearance of the display. ( see page 19 ) • Never use any type of alcohol except Ethanol for Disinfection (Ethanol 80 vol%). Do not use paint

thinner, benzene or similar solutions to clean Canal Measurement Module main unit. ( see page 19 ) • Avoid spilling chemical solutions used for treatment on Canal Measurement Module main unit. These

chemicals could damage, deform or discolor Canal Measurement Module main unit. Use extra caution to avoid spilling formalin cresol (FC) and sodium hypochlorite as they are quite strong. Wipe up any chemical spills immediately. (Some chemicals may leave traces even if wiped up immediately.) ( see page 19 )

Cord


Page6

Liquid Crystal Display

Set Switch

Select Switch

Mode Switch

File Holder

Contrary Electrode (Lip Clip)

Probe Cord


Power Switch

2. Parts Identification Accessories

Probe Cord (1) File Holder (3) Contrary Electrode (5)

Tester (1) AA Battery (3) Long File Holder (option)


3. Assembling the Unit Placing the Batteries

NOTE • Canal Measurement Module is shipped without the

batteries installed. Remove the cover and install the 3 AA batteries.

1. Hold the cover and slide the stopper on the bottom towards the liquid crystal display.

2. Slide the cover in the direction indicated by the arrow in the

illustration and remove it from Canal Measurement Module.

3. Place the 3 AA batteries included in the package as indicated

on the unit. (1) Insert the batteries by first pressing center of the minus

end against its spring contact and then sliding the plus end down into place.

(2) Make sure the contacts are not bent or damaged.

NOTE • Do not reverse the plus and

minus poles. • Never allow the spring contact

to push against the edge of the battery. This could damage the outer cover causing a short or a leakage of battery liquid.

4. Line up the tabs on the cover with the notches on Canal Measurement Module and slide the cover on.

5. Slide the cover all the way down until it is securely attached.

NOTE • If the catch on the bottom is not back in its original place

after attachment, push it in the direction shown by the arrow in the illustration.

• After installation, give the cover a light tug to confirm it is securely attached

Notches Tabs

Canal Measurement Module Cover

Cover

2

Cover Canal Measurement Module

4

5

Stopper

Cover


1

3


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4. Before Using the Unit Connecting the Probe Cord

1. Insert the probe cord completely into the jack on the left side of Canal Measurement Module.

NOTE • Handle Canal Measurement Module carefully; do not drop,

bump or expose it to other kinds of impacts or shocks. Rough handling could cause damage.

• Make sure the plug is securely plugged into the jack. A poor connection can cause malfunction.

• Do not drop anything on or bang the plug after it has been inserted into the jack.

2. Insert the file holder’s gray male plug into the gray female connector on the probe cord. Insert the contrary electrode into the white female connector on the probe cord.

NOTE • Make sure to match colors of the file holder and contrary

electrode to the probe cord. • Measurements cannot be made if these connections are

reversed. Checking the Function

This checking procedure should be followed at the beginning of every day.

1. Press the Power switch to turn on the unit. The measurement display will appear.

* The unit will automatically turn off after ten minutes of non-use.

2. Check that the probe cord is properly plugged into the jack.

3. Check that the file holder and contrary electrode are properly connected to the probe cord.

4. Contact metal part of the file holder with contrary electrode.

Probe Cord Plug

Probe Cord Connector

Contrary Electrode

Probe Cord Connector (gray)

File holder Plug (gray)

Plug in

(white)

Plug in

Contrary Electrode

File Holder Contact

Power Switch


5. Check that all the canal length indicator bars on the display

are lit, the word “APEX” flashes and audible beep becomes continuous.

WARNING • Check the unit’s operation before each patient. If the

indicators in the display do not all appear normally, the instrument may not be able to make an accurate measurement. In this case, stop using the instrument and have it repaired.

Checking the Function with the Tester

Check the root canal measurement’s performance with the tester once a week.

1. Press the Power switch to turn on the unit.

2. Insert the tester into the probe cord jack.

Check that the meter indicates within ±3 bars from (above or below) the 1.

* The meter may jump when the tester is inserted. If it does, wait for about one second until the meter stabilizes and then check the reading.

* If the reading is 4 or more bars from the 1, the unit will not make accurate measurement. In this case, contact your local dealer or J. Morita regional office.

3. Remove the tester and connect the probe cord.

4. Connect the file holder and contrary electrode to the probe cord.

5. Contact metal part of the file holder with contrary electrode.

Check that all the canal length indicator bar on the display are lit, the word “APEX” flashes and audible beep becomes continuous.

Must be within this range

Tester

Probe Cord Jack


Page10

5. Operating the Unit Operation Panel Display and Switches

Setting and Changing Memory

Use the Mode Switch to select M1, M2 or M3. Use the Select switch to select sound volume and Apical Line. Use the Set Switch to set the memory content.

Press Mode to select the memory.

Press

Press Select to select the item.

Press

(The display will briefly flash on and off.)

Press Set to set the memory content.

Press

Sound volume selected

M1 (Memory 1)

M2 (Memory 2)

M3 (Memory 3)

Root Canal Measurement

Mode 1


Mode 2


Mode 3

Apical Line selected.

The apical line can be set anywhere between 2 and Apex.

* All memory settings will be retained even after the unit is turned off. Simply select M1, M2, or M3 to use those memory settings.

WARNING • Check the settings displayed after selecting memories.

Alarm Sound Selection In case 2 or more units are being used, there are two different sounds for the alarm so that you can tell one from the other. To change the sound, hold down the Set switch and turn the unit on.

* The sound that signals switch operation will also change. * The sound cannot be memorized separately by the three memories (M1, M2 and M3). * Turn the unit off to save the selection.

Flashes

Apical LineFlashes

Sound Volume Off, Low, High Battery Power Indicator

This bar graph indicates remaining battery power. Replace the batteries when this indicator begins flashing.

WARNING • Never use the unit if the

battery power indicator is flashing on and off. The unit will not function properly if the battery power is low.

* Battery power indicator

also appears when Handpiece / LED Moduleis connected.

Memory (M1, M2, and M3) Refer to the section "Setting and Changing Memory" for details.

Apical Line Use this point as an estimate for root canal measurement. It can be set anywhere between 2 and Apex.

Canal Length Indicator Bar

Meter Gauge * The numerals 1, 2 and 3 do

not represent length in millimeters.

Power Mode Select Set Switch Switch Switch Switch

Turn the sound off.

Set the sound volume low.

Set the sound volume high.


Meter Display

■ The position of the file tip is shown by the canal length indicator bar on the display. The apical line flashes on and off once file is inserted into the root canal.

NOTE • Do not let the file touch the gums. This will cause the

meter to jump to Apex. • If the canal is extremely dry, the meter may not move until

it is quite close to the apex. If the meter does not move, try moistening the canal with oxydol or saline.

• Occasionally the canal length indicator bar makes a sudden and large movement as soon as the file is inserted into the root canal, but it will return to normal as the file is advanced down towards the apex.

WARNING • In some cases such as a blocked canal, a measurement

cannot be made. (For details, see page 14, “Root Canals not suitable for Electronic Measurement.”)

• Always check the measurement with an x ray. In some cases, an accurate measurement cannot be made because of the canal shape, unusual cases, or poor performance of the instrument.

• Stop using the instrument immediately if you sense something odd or abnormal while taking a measurement.

■ The meter’s 0.5 reading indicates that the tip of the file is in

the apical constriction.

* The numerals on the meter gauge do not represent millimeters.

■ If the file tip passes the point indicated by the apical line, the

alarm sound will change from beeping to solid tone. If the file tip reaches the major foramen, the word “APEX” and the little triangle next to the apical line will start to flash.

Flashes

Apical Line

Flashes

Flashes


Page12

Operating the Unit

1. Turn on the unit.

2. Hook the contrary electrode in the corner of the patient's mouth.

WARNING

• Do not use an ultrasonic scaler with the contrary electrode attached to the patient. This is dangerous because electrical noise from the scaler could interfere with canal measurements and motor operation.

• Make sure that the contrary electrode, file holder, handpiece file electrode, etc., do not come into contact with an electric power source such as an electrical socket. This could result in a severe electrical shock.

NOTE • The contrary electrode could cause an adverse reaction if

the patient has an allergy to metals. Ask the patient about this before using the contrary electrode.

• Take care that medicinal solutions such as formalin cresol (FC) or sodium hypochlorite do not get on the contrary electrode or the file holder. These could cause an adverse reaction such as inflammation.

3. Clip the file holder to the metal shaft of the file.

NOTE • Always clip the file holder to the upper part of file shaft,

near the handle. The metal and plastic part of the file holder can be damaged if they are attached to the file’s cutting part or the transition to the cutting part.

1. Press in direction of arrow with the thumb.

2. Clip file. 3. Release thumb.

File Holder.

Press

Contrary Electrode

Corner of Mouth

File or Reamer Handle

Metal part of file holder

Cutting part and transition to cutting part.

* Do not clip onto this part!


NOTE • Use files and reamers with plastic handles only. If the file has a metal handle, electrical leakage will

occur when the handle is touched by fingers and it will prevent an accurate root canal measurement. Even if the file handle is made of plastic, make sure not to touch the metal part of the file with finger.

• Do not use damaged file holders. An accurate measurement cannot be made using a damaged file holder. • Clip the file as shown in illustration #1 below. If the file is forced into the position shown in illustration

#2, it may not make an accurate measurement and the file holder could be damaged.

4. Press the mode switch to select memory 1, 2 or 3 (M1, M2

or M3).

* See “Setting and Changing Memory", on page 10 for how to set the memory contents.

* While an actual measurement is being made, none of the switches, except the power switch, will work.

5. Insert the file (in most case size 10) until the meter reads 0.5

(this point can be recognized by the change in the alarm sound as well). Then advance the file with slow clockwise turns until the word “APEX” begins to flash. When the apex is reached, turn the file with slow counter clockwise turns until meter reads 0.5 again. Since some canals have multiple constrictions, it is essential that the file be taken to the apex then returned to the apical constriction (0.5 reading). Position the rubber stopper on the tooth surface as a reference point to determine the root canal’s working length.

■ After root canal’s working length is determined, turn off the unit, disconnect the probe cord from the main unit and remove the file holder and contrary electrode from the probe cord.

* Working length differs somewhat depending on each individual tooth. The discrepancy must be judged by the dentist.

NOTE

• Make sure to take an x-ray to check the results.

Mode Switch

1

2

Rubber Stopper

File Holder

0.5 Reading


Page14

Root Canals not suitable for Electronic Measurement Reading (EMR)

Accurate measurement cannot be obtained with the root canal conditions shown below. There may be other cases that an accurate measurement cannot be made.

Root Canal with a large apical foramen Root canal that has an exceptionally large apical foramen due to a lesion or incomplete development cannot be accurately measured; the results will show shorter measurement than the actual length. Root Canal with blood, saliva or a chemical solution overflowing from the opening If blood, saliva, or a chemical solution overflow from the opening of the root canal and contacts the gums, this will result in electrical leakage and an accurate measurement cannot be obtained. Wait for bleeding to stop completely. Clean the inside and opening of the canal thoroughly to get rid of all blood, saliva and chemical solutions and then make a measurement.

Broken crown If the crown is broken and a section of the gingival tissue intrudes into the cavity surrounding the canal opening, contact between the gingival tissue and the file will result in electrical leakage and an accurate measurement cannot be obtained. In this case, build up the tooth with a suitable material to insulate the gingival tissue. Fractured tooth Leakage through a branch canal Fractured tooth will cause electrical leakage and an accurate measurement cannot be obtained. A branch canal will also cause electrical leakage. Re-treatment of a root filled with gutta-percha The gutta percha must be completely removed to eliminate its insulating effect. After removing the gutta percha, pass a small file all the way through the apical foramen and then put a little saline in the canal but do not let it overflow the canal opening.

Build-up

Clean

Fracture

Branch

Gutta-Percha


Crown or metal prosthesis touching gingival tissue Accurate measurement cannot be obtained if the file touches a metal prosthesis that is touching gingival tissue. In this case, widen the opening at the top of the crown so that the file will not touch the metal prosthesis before taking a measurement.

Cutting debris on tooth Pulp inside canal Thoroughly remove all cutting debris on the tooth. Thoroughly remove all the pulp inside the canal; otherwise an accurate measurement cannot be made. Caries touching the gums In this case, electrical leakage through the caries infected area to the gums will made it impossible to make an accurate measurement. Blocked Canal The meter will not move if the canal is blocked. Open the canal all the way to the apical constriction to measure it.

Extremely dry canal If the canal is extremely dry, the meter may not move until it is quite close to the apex. In this case, try moistening the canal with oxydol or saline.

Caries touches gums

Blocked

Too Dry

Crown

Debris

Pulp


Page16

EMR and Radiography

Sometimes the EMR and the x-ray image do not correspond. This does not mean that the unit is not working properly or that the x-ray exposure is inaccurate.

* Frequently, the actual apical foramen and anatomical apex do not correspond exactly. The actual apical foramen may be located towards the crown. In this case, the x-ray image will seem to indicate that the file has not reached the apex.

* Depending on the penetration angle of the x-ray beam, the apex may not appear correctly. The position of the apical foramen may appear to be located differently than it actually is.

X-ray Film Apical foramen is located up towards the crown.

X-ray Tube


6. After Using the Unit

1. Turn off the unit.

* The unit will automatically turn off after 10 minutes of non-use.

2. Disconnect the probe cord from the unit and remove the file holder and contrary electrode from the probe cord.

NOTE

• When disconnecting and connecting the contrary electrode, probe cord and file holder, never pull or push on the cords themselves; always grip the connectors.

• Do not wrap the probe cord around the body of the main tube.

Replacing Batteries

Replace the batteries as soon as the battery power indicator starts flashing.

* To be on the safe side, replace the batteries when the battery power indicator displays two lines.

WARNING • Do not use the unit if the battery power display is flashing.

The unit may not function properly if the battery power is low.

1. Hold the cover and slide the stopper on the bottom towards

the liquid crystal display. 2. Slide the cover in the direction indicated by the arrow in the

illustration and remove it from Canal Measurement Module.

Cord

Catch

Cover


1

Cover

2


Page18

3. Take out the old batteries and replace them with new ones.

Make sure the plus and minus poles are correctly lined up.

(1) Insert the batteries by first pressing center of the minus end against its spring contact and then sliding the plus end down into place.

(2) Make sure the contacts are not bent or damaged.

NOTE

• Do not reverse the plus and minus poles.

• Never allow the spring contact to push against the edge of the battery. This could damage the outer cover causing a short or a leakage of battery liquid.

4. Line up the tabs on the cover with the notches on Canal Measurement Module and slide the cover on.

5. Slide the cover all the way down until it is securely attached.

NOTE

• If the catch on the bottom is not back in its original place after attachment, push it in the direction shown by the arrow in the illustration.

• After installation, give the cover a light tug to confirm it is securely attached.

NOTE

• Always use alkaline AA batteries. • Never use rechargeable nickel-hydrogen or nickel-cadmium batteries. • Replace all three batteries at the same time. • Make sure that the plus and minus poles are correctly aligned. • Never use batteries that are leaky, deformed, discolored or otherwise abnormal. • Dispose of old batteries according to local codes and regulations. • In case of battery leakage, carefully dry the battery terminals and remove all of the leaked liquid.

Replace the battery with a new one.

* Overheating could result if the above conditions are not adhered to. * The three AA alkali dry cells used for this unit will last for about 100 hours of use. (This equals 6 to 12

months at normal rates of usage.)

Cover Canal Measurement Module

4

5

Notches Tabs

Canal Measurement Module Cover


7. Sterilization and Replacement Parts Sterilization

a. Autoclavable Components [ File Holder and Contrary Electrode ] Recommended temperature and time: 135°C (275°F), 6 minutes minimum with a sterilization pouch. Minimum drying time after sterilization: 10 minutes.

WARNING • Autoclave file holder and contrary electrode after each patient.

NOTE • Do not sterilize in any way other than autoclave. • Thoroughly clean and wash the components before autoclaving. If chemical solutions or foreign

debris are not removed, autoclaving could damage or deform the components. • Autoclave and dry temperatures must not exceed 135°C (275°F). • It is highly recommended to put the contents in a sterilization pouch for autoclaving. • Never autoclave probe cord.

b. Non-Autoclavable Components

[ Probe Cord ] * Wipe probe cord with a piece of gauze dampened with Ethanol for Disinfection (Ethanol 80 vol%).

NOTE • Never wipe probe cord with any type of alcohol except Ethanol for Disinfection (Ethanol 80 vol%).

c. Canal Measurement Module Main Unit

* To clean the surface of Canal Measurement Module main unit, use a soft cloth to apply a little neutral detergent and then rinse it with a cloth moistened with water.

NOTE • Occasionally, static electricity produced by wiping the liquid crystal display with a dry cloth may

affect the appearance of the display. • Never use any type of alcohol except Ethanol for Disinfection (Ethanol 80 vol%). Do not use paint

thinner, benzene or similar solutions to clean Canal Measurement Module main unit. • Avoid spilling chemical solutions used for treatment on Canal Measurement Module main unit.

These chemicals could damage, deform or discolor Canal Measurement Module main unit. Use extra caution to avoid spilling formalin cresol (FC) and sodium hypochlorite as they are quite strong. Wipe up any chemical spills immediately. (Some chemicals may leave traces even if wiped up immediately.)

Replacement Parts

* Replace parts as necessary depending on degree of wear and length of use. * Order replacement parts from your local dealer or J. Morita regional office.

Storage

* Store the unit where it will not be exposed to x-rays or direct sunlight and where the ambient temperature range is between -10°C / 14°F and 70°C / 158°F ; humidity between 8 RH and 80 RH % (without condensation) and atmospheric pressure between 700 hPa and 1,060 hPa.

* If the unit has not been used for a long time, make sure it works properly before using. * Always remove the batteries prior to storing or shipping the unit. * Working life: The working-life of this unit is 6 years from the date of shipment provided it is regularly and

properly inspected and maintained.


Page20

8. Maintenance and Inspection

* The user (hospital, medical institute or clinic) is responsible for inspection and maintenance of the units.)

Regular Inspection * This unit should be inspected every 6 months in accordance with the following maintenance and inspection

items.

Maintenance and Inspection Items 1. Check that the Power switch turns the unit on and off properly. 2. Insert the Tester and check that the indicator is within ±3 lines of 1 on the meter. 3. Check that the Mode switch changes the memory from M1 to M2 to M3 etc. 4. Check that the Select and Set switches work properly. 5. Check that the probe cord can be properly plugged into its jack. 6. Check that the file holder's plug can be connected properly to the probe cord and that the file holder can

be clipped onto a file. Check the contrary electrode can be plugged into its probe cord connector.


9. Troubleshooting

If the unit does not seem to be working properly, the user should first try to troubleshoot to solve operational problems. If the problems can not be solved after referring to the list below, contact your local dealer or J. Morita regional office.

Problem Check Points Response

No power Check battery installation.

Check battery power.

Install batteries properly.

Replace batteries.

Cannot make a Measurement

Check cord connections.

Check probe cord for broken wire.

Check that all connections are properly secured.

Touch the contrary electrode to the file holder to check probe cord conductivity.

No sound Check if sound is turned off. Turn on the sound.

Cannot switch memories

Cannot change memory settings

Is a measurement being performed?

Does the switch work?

Switches do not work during measurement.

Switch may be broken.

Display does not appear. Is there a sound when the unit is turned on and off?

Replace batteries if there is no sound. Broken display if there is a sound.

Canal Length Indicator is unstable.

Is contrary electrode making good contact with oral mucosa?

Is the file holder dirty?

Make sure the contrary electrode makes good contact with the oral mucosa.

Clean the file holder with Ethanol for Disinfection (Ethanol 80 vol%).

Canal Length Indicator overreacts or is too sensitive. (Measurements are too short. Poor accuracy. Erratic results.)

Is blood or saliva overflowing from the opening of the crown?

Is the root canal filled with blood, saliva or chemical solutions?

Is the tooth surface covered with cutting debris or chemical solutions?

Is the file touching the gingival tissue?

Is there pulp tissue left inside the root canal?

Is the file touching a metal prosthesis?

Are proximal surfaces infected with caries?

If blood or other fluids overflow the canal, the current will leak to the gums and the meter will jump to Apex. Clean the canal, canal opening and tooth crown thoroughly.

The canal length indicator bar may suddenly swing when it breaks the surface of fluids inside the root canal, but it will return to normal as it approaches the apex.

Clean entire tooth surface.

This will cause the canal length indicator bar to suddenly jump all the way to the “APEX”.

An accurate measurements cannot be obtained if a large amount of pulp tissue is left inside the root canal.

Touching a metal prosthesis with the file allows a flow of current to the gingival tissue or periodontal pocket and will cause the meter to jump to the “APEX”.

Current can flow through the caries infected area to the gums and prevent an accurate measurement from being made.


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Problem Check Points Response

Canal Length Indicator overreacts or is too sensitive. (Measurements are too short, poor accuracy or erratic results.)

Are there lateral canals or is the tooth fractured?

Does a broken crown allow leakage of electric current?

Is there a lesion at the apex?

Is the file holder broken or dirty?

The canal length indicator bar may jump to “APEX” when it reaches the opening of a lateral root canal or the opening of a fractured tooth which allows the current to flow to the gingival tissue.

Build up an insulating barrier to stop the leakage.

A lesion can destroy the apical foramen through absorption and an accurate measurement cannot be obtained.

Replace or clean the file holder.

Canal Length Indicator bar does not move (except when very near the apical foramen).

Is root canal blocked?

Is the apical foramen very large and open?

Is root canal extremely dry?

A small file in a large root canal.

Canal length indicator will return to normal when the file reaches apical constriction.

If the apical foramen is large or wide open and not completely formed, the canal length indicator bar will suddenly jump when the file tip gets close to the apex.

Moisten the root canal with hydrogen peroxide or a saline solution.

Increase the size of the file.

10. Replacement Parts List

1 2 3

4 5

No. Description

1 Probe Cord

2 File Holder (5)

3 Contrary Electrode (5)

4 Tester

5 Long File Holder (1)


11. Technical Description

Main unit and accessories Model DP-ZX-VL Type RCM-EX

Classification Safety according to IEC 60601-1, IEC 60601-1-2, UL 60601-1, ISO 11498, ISO 7785-2, CAN/CSA C22.2 No.601.1-M90 European Directive 93/42/EEC IIa Canada Medical devices Class II

Type of Protection Battery operated against Electric Shock

Degree of Protection Type B applied part against Electric Shock

Degree of Protection IPX O (IEC 60529 )

Mode of Operation Continuous

Intended use It can be used to measure the length of the canal.

Main unit Rated Voltage DC 4.5 V (with battery operation)

Rated Current max. 0.03 A (with battery operation)

Power Consumption 0.135 VA (with battery operation)

Dimensions Canal Measurement Module 115 ± 20(mm) x 105 ± 20(mm) x 105 ± 20(mm)

Weight Canal Measurement Module Approximately 370 g

Operation, Transport and Storage Conditions for the main unit Operating Conditions

Ambient temperature range +10° / 50° F ~ +40° C / 104° F

Relative humidity 30 ~ 80 RH % without condensation

Atmospheric pressure range 800~ 1,060 hPa

Transport and Storage Conditions

Ambient temperature range -10° / 14° F ~ +70° C / 158° F

Relative humidity 8 ~ 80 RH % without condensation

Atmospheric pressure range 700 ~ 1,060 hPa


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Symbols Rated Label * Distributor on the label is different depending on the market where it is installed.

Operation Instructions

Package

Disposal The package should be recycled. Metal parts of the device are disposed as scrap metal. Synthetic materials, electrical components, and printed circuit boards are disposed as electrical scrap. Material must be disposed according to the relevant national legal regulations. Consult specialized disposal companies for this purpose. Please inquire of the local city / community administrations concerning local disposal companies. Service ROOT ZX II may be repaired and serviced by • the technicians of J. Morita’s subsidiaries all over the world. • technicians employed by authorized J. Morita dealers and specially trained by J. Morita. • independent technicians specially trained and authorized by J. Morita.

Example of Serial Number

SER.No. O A 0 0 0 1

Year of Manufacture O: 2000 P: 2001 Q: 2002 R: 2003

Month of Manufacture A: Jan. B: Feb. C: March D: April L: Dec.

Lot No. 0001

Authorized representative in the European Community

Temperature Limitation

Type Rated Input Voltage

Model

Serial Number

Internally Powered Equipment

Manufacturer

ROOT ZX II conforms with the European Directive, 93 / 42 / EEC which includes the requirements for electromagnetic compatibility.

Attention, consult accompanying documents. Type B applied part

Rated Input Ampere

cTUVus certification mark for the U.S. and Canadian


Appendix- Electromagnetic declaration

*Indicates data when Handpiece / LED Module is connected to Canal Measurement Module.

Guidance and manufacturer’s declaration – electromagnetic emissions

The DP-ZX-VL is intended for use in the electromagnetic environment specified below. The customer or the user of the DP-ZX-VL should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11 Group 1

The DP-ZX-VL uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class B

*Harmonic emissions IEC61000-3-2 Class A

*Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

The DP-ZX-VL is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.


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*Indicates data when Handpiece / LED Module is connected to Canal Measurement Module.

Guidance and manufacturer’s declaration – electromagnetic immunity


Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

+6 kV contact +2, 4, 6 kV contact Electrostatic discharge (ESD) IEC 61000-4-2 +8 kV air +2, 4, 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

+2 kV for power supply lines

+2.0 kV for power supply lines

*Electrical fast transients/bursts IEC 61000-4-4 +1 kV for input/output

lines +1.0 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

+1 kV line(s) to line(s) +0.5, 1 kV line(s) to line(s)

*Surge IEC 61000-4-5

+2 kV line(s) to earth +0.5, 1, 2kV line(s) to earth

Mains power quality should be that of a typical commercial or hospital environment.

<5% UT (>95% dip in UT) for 0.5 cycle

0% UT (>95% dip in UT) /0.5 periods

40% UT (60% dip in UT ) for 5 cycles

40% UT (60% dip in UT ) /5 periods

70% UT (30% dip in UT ) for 25 cycles

70% UT (30% dip in UT ) /25 periods

*Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11

<5% UT (>95% dip in UT) for 5 sec

0% UT /5 sec.

Mains power quality should be that of a typical commercial or hospital environment. If user of the DP-ZX-VL requires continued operation during power mains interruptions, it is recommended that the DP-ZX-VL be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m 3.15 A/m Power frequency magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note UT is the a.c. mains voltage prior to application of the test level.


Guidance and manufacturer’s declaration – electromagnetic immunity


Immunity test IEC 60601 test level

Compliance level Electromagnetic environment - guidance

Portable and mobile RF communications equipment should be used no closer to any part of the DP-ZX-VL, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 V

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

d = 1.11 P d = 0.95 P 80 MHz to 800 MHz d = 1.89 P 800MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected be absorption

and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for ratio (cellular/cordless) telephones and land

mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DP-ZX-VL is used exceeds the applicable RF compliance level above, the DP-ZX-VL should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting of relocating the DP-ZX-VL.

b Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.


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Recommended separation distances between portable and mobile RF communications equipment and the DP-ZX-VL.

The DP-ZX-VL is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the DP-ZX-VL can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DP-ZX-VL as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter m Rated maximum output

power of transmitter W 150 kHz to 80 MHz

d = 1.2 P 80 MHz to 800 MHz

d = 1.2 P 800 MHz to 2.5 GHz

d = 2.3 P 0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.69 3.69 7.38

100 11.67 11.67 23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

Essential Performance Noise does not substantially change measurement. Accessory

Probe Cord Code No.7503661

WARNING • Use of the parts other than those accompanied or specified by J. Morita Mfg. Corp. may result in

increased EMC emissions or decreased EMC immunity of the DP-ZX-VL.


12. Warranty

1 Year Limited Warranty 1. The manufacturer gives a worldwide guarantee for one year beginning from the date of purchase.

Within this period any defect that is due to faulty manufacturer or material will be remedied by repair or replacement at the judgment of the manufacturer or its distributor.

2. Warranty repair and service: In the event of a claim under this guarantee, the device is to be sent to the service facility of the distributor, postage and shipping paid, including a short description of the problem, and a copy of the sales receipt from the dealer as proof of purchase and title to warranty. Always ship prepaid. Distributor does not accept collect shipments.

3. In the case of damage caused by wear and tear, careless handling and repairs not carried out by an authorized service facility, the warranty ceases to be valid. This guarantee may not form the basis for any claims for damages, in particular not for compensation of consequential damages.

The buyer assumes responsibility for damage due to dropping of the unit, improper use and utilization of product and chemicals other than those stated in this instruction manual for cleaning. It is the customer’s responsibility to maintain the exact rated voltage indicated at the bottom of the unit, and the office maintains electrical outlets for proper performance of the unit.

4. This warranty does not include the external accessories, file electrode, batteries, or transportation costs.

ATTENTION * Inspect the unit every 6 months in accordance with the Maintenance and Inspection items on page 20.

* Refer to the parts replacement lists and replace worn parts whenever necessary.

1. J. Morita Mfg. Corp. will not be responsible for accidents, equipment damage, or bodily injury resulting from repairs made by personnel not authorized by the J. Morita Mfg. Corp.

2. J. Morita Mfg. Corp. will not be responsible for accidents, equipment damage, or bodily injury resulting from any changes, modifications, or alterations of its products.

3. J. Morita Mfg. Corp. will not be responsible for accidents, equipment damage, or bodily injury resulting from the use of products or equipment made by other manufacturers, except for those procured by the J. Morita Mfg. Corp.

4. J. Morita Mfg. Corp. will not be responsible for accidents, equipment damage, or bodily injury resulting from maintenance or repairs using parts or components other than those specified by the J. Morita Mfg. Corp. and in their original condition.

5. J. Morita Mfg. Corp. will not be responsible for accidents, equipment damage, or bodily injury resulting from operating the equipment in ways other than the operating procedures described in this manual or resulting from not following the cautionary remarks and warnings in this manual.

6. J. Morita Mfg. Corp. will not be responsible for accidents, equipment damage, or bodily injury resulting from workplace conditions and environment or installation conditions such as improper electrical power supply which do not conform to those stated in this manual.

7. J. Morita Mfg. Corp. will not be responsible for accidents, equipment damage, or bodily injury resulting from fires, earthquakes, floods, lightning, natural disasters, or acts of God.

8. J. Morita Mfg. Corp. will supply replacement parts and be able to repair the product for a period of 10 years after the manufacture of the product has been discontinued.

PUB. M8037-EA-2 Printed in Japan

J. MORITA MFG. CORP. 680 Higashihama Minami-cho, Fushimi-ku, Kyoto, 612-8533 Japan

www.jmorita-mfg.com

Distributors

J. MORITA CORPORATION Tokyo Office : 11-15, 2-Chome Ueno, Taito-ku, Tokyo, 110-8513 Japan

Osaka Office : 33-18, 3-Chome Tarumi-cho, Suita, Osaka, 564-8650 Japan

J. MORITA USA, Inc. 9 Mason lrvine, CA 92618 U.S.A.

TEL:+1-949-581-9600 FAX: +1-949-465-1095

J. MORITA EUROPE GMBH Justus-Von-Liebig-Strasse 27A, D-63128 Dietzenbach Germany

TEL: +49-6074-836-0 FAX: +49-6074-836-299

Siamdent Co., Ltd. 71/10 Bangpakong Industrial Park I, Bangna-Trad, KM. 52, Bangpakong

Chachuengsao 24130, Thailand

TEL: +66-38-57-3042 FAX: +66-38-57-3043

J. MORITA CORPORATION Australia and New Zealand Suite 2.05, Aero 247 Coward Street Mascot NSW 2020, Australia

TEL: +61-2-9667-3555 FAX: +61-2-9667-3577

EU Authorized Representative under the European Directive 93/42/EEC

MEDICAL TECHNOLOGY PROMEDT CONSULTING GMBH

Altenhofstraße 80, 66386 St. Ingbert, Germany

TEL: +49-6894-581020 FAX: +49-6894-581021

The authority granted to the authorized representative, MEDICAL TECHNOLOGY

PROMEDT Consulting GmbH, by J. Morita Mfg. Corp. is solely limited to the work

of the authorized representative with the requirements of the European Directive

93/42/EEC for product registration and incident report.

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